TERBINAFINE HYDROCHLORIDE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (TERBINAFINE - UNII:G7RIW8S0XP)

Available from:

Rebel Distributors Corp

INN (International Name):

TERBINAFINE HYDROCHLORIDE

Composition:

TERBINAFINE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Terbinafine hydrochloride tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium) (see DOSAGE AND ADMINISTRATION and CLINICAL STUDIES ).   Prior to initiating treatment, appropriate nail specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis of onychomycosis. Terbinafine hydrochloride tablets are contraindicated in individuals with hypersensitivity to terbinafine or to any other ingredients of the formulation.

Product summary:

Terbinafine Hydrochloride Tablets 250 mg are supplied as white, round flat faced beveled edge tablets debossed with IG on one side and ‘209’ on the other side.           Bottles of 30               NDC 21695-630-30           Bottles of 42              NDC 21695-630-42           Bottles of 45               NDC 21695-630-45           Bottles of 60              NDC 21695-630-60           Bottles of 90               NDC 21695-630-90 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].  Protect from light.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE TABLET
REBEL DISTRIBUTORS CORP
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TERBINAFINE HYDROCHLORIDE TABLETS
DESCRIPTION
Terbinafine Hydrochloride Tablets contain the synthetic allylamine
antifungal compound terbinafine
hydrochloride USP.
Chemically, terbinafine hydrochloride is (E)-
_N_
-(6,6-dimethyl-2-hepten-4-ynyl)-
_N_
-methyl-1-naphthalenemethanamine hydrochloride. The empirical formula
C
H
CIN with a molecular weight of 327.90, and the following structural
formula:
Terbinafine hydrochloride USP is a white to off-white fine crystalline
powder. It is freely soluble in
methanol and methylene chloride, soluble in ethanol, and slightly
soluble in water.
EACH TABLET CONTAINS:
_Active Ingredients:_
Terbinafine hydrochloride USP (equivalent to 250 mg base)
21
26
_Inactive Ingredients:_
Microcrystalline cellulose, sodium starch glycolate, colloidal silicon
dioxide, hypromellose,
magnesium stearate
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Following oral administration, terbinafine is well absorbed (>70%) and
the bioavailability of terbinafine
hydrochloride tablets as a result of first-pass metabolism is
approximately 40%. Peak plasma
concentrations of 1 mcg/mL appear within 2 h after a single 250 mg
dose; the AUC (area under the
curve) is approximately 4.56 mcg·h/mL. An increase in the AUC of
terbinafine of less than 20% is
observed when terbinafine hydrochloride is administered with food. No
clinically relevant age-
dependent changes in steady-state plasma concentrations of terbinafine
have been reported. In patients
with renal impairment (creatinine clearance ≤ 50 mL/min) or hepatic
cirrhosis, the clearance of
terbinafine is decreased by approximately 50% compared to normal
volunteers. No effect of gender on
the blood levels of terbinafine was detected in clinical trials. In
plasma, terbinafine is >99% bound to
plasma proteins and there are no specific binding sites. At
steady-state, in comparison to a single dose,
the peak concentration of terbinafine is 25% higher and plasma AUC
increases by